BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 25 G X 1 IN

    MDR report key: 15341873 · Received September 1, 2022

    Report

    Report Number
    1213809-2022-00537
    Event Type
    Malfunction
    Date Received
    September 1, 2022
    Date of Event
    August 9, 2022
    Report Date
    October 3, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095811
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: FOUR PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A LOOSE, UNPACKAGED AND UNSHIELDED SYRINGE WITH NEEDLE OBSERVED ON THE TOP OF SEALED SAMPLES INSIDE THE BOX. POTENTIAL ROOT CAUSES FOR THE UNPACKAGED SYRINGE DEFECT ARE ASSOCIATED WITH THE PACKAGING PROCESS. A QUALITY ALERT WILL BE SENT TO OUT THE MANUFACTURING FACILITY FOR THIS DEFECT. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 0281238. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 25 G X 1 IN EXPERIENCED A OPEN PACKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WORK AS AN RN AT A FAMILY DOCTORS OFFICE IN GUELPH ONTARIO. WE RECEIVED AN ORDER OF SYRINGES AND UPON MY OPENING THE BOX TODAY AND ALMOST STABBED MYSELF WITH AN UNPACKAGED 25G 1¿ SYRINGE, LYING RIGHT AT THE TOP OF THE BOX.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 25 G X 1 IN EXPERIENCED A OPEN PACKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WORK AS AN RN AT A FAMILY DOCTORS OFFICE IN GUELPH ONTARIO. WE RECEIVED AN ORDER OF SYRINGES AND UPON MY OPENING THE BOX TODAY AND ALMOST STABBED MYSELF WITH AN UNPACKAGED 25G 1¿ SYRINGE, LYING RIGHT AT THE TOP OF THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1537772 BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 25 G X 1 IN PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309581 0281238 30382903095811

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown